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Completed

NCT Number: NCT01665092

Rapid Administration of Carnitine in sEpsis

Prior work has shown that exogenous L-carnitine administration enhances glucose and lactate oxidation, attenuates fatty acid toxicity, and improves endothelial-smooth muscle coupling and cardiac mechanical efficiency. The overall goal of this proposal is to investigate L-carnitine as a novel adjunctive treatment of septic shock. In this study the investigators will test our primary hypothesis: Early adjunctive L-carnitine administration in vasopressor dependent septic shock will significantly reduce cumulative organ failure at 48 hours with an associated decrease in 28-day mortality suggesting the need for further phase III study. To accomplish this the investigators will conduct a phase II, double blinded, placebo controlled, adaptive randomized trial of 250 eligible patients with vasopressor-dependent septic shock. Study subjects will be assigned to one of four arms: low (6g), medium (12g) or high (18g) dose intravenous L-carnitine or placebo for 12 hours as a part of early resuscitative care.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

University of Alabama Birmingham, Birmingham, Alabama, United States

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Suspected or confirmed infection (examples include but are not limited to: white cells in a normally sterile body fluid; perforated viscus; radiographic evidence of pneumonia in clinical symptoms; a syndrome associated with a high risk of infection e.g. cellulitis, cutaneous abscess, ascending cholangitis, toxic shock syndrome, fever of unknown origin with high suspicion of infectious etiology)
  • Any two of four criteria of systemic inflammatory response as defined by the 2001 ACCP/SCCM Consensus Conference Committee;
  • Recognition of septic shock and initiation of quantitative resuscitation within 24 hours of enrollment;
  • Requirement of high dose vasopressors for ≥4 hours to treat shock: Norepinephrine > 0.05mcg/kg/min; dopamine >10mcg/kg/min; Phenylephrine >0.4 mcg/kg/min; epinephrine > 0.05 mcg/kg/min;
  • Cumulative sequential organ failure assessment (SOFA) score of ≥ 6;
  • Blood lactate level of >2.0 mMol/L.

Exclusion criteria

  • Age <18 years;
  • Pregnancy or breastfeeding;
  • Any primary diagnosis other than sepsis;
  • Established Do Not Resuscitate status or advanced directives restricting aggressive care or treating physician deems aggressive care unsuitable;
  • Any history of seizures or a known seizure disorder;
  • Any known inborn error of metabolism;
  • Anticipated requirement for surgery that would interfere with the 12 hour infusion time;
  • Active participation in another interventional study;
  • Cardiopulmonary resuscitation (chest compression or defibrillation) prior to enrollment;
  • Known systemic allergy to L-carnitine.
  • Severe immunocompromised state (e.g. subject has neutropenia [receiving cytotoxic chemotherapy with absolute neutrophil count <500/uL or expected to decline to < 500 uL within the next three days).
  • Active Treatment with Coumadin

Treatment and study plan

Levo-Carnitine

Drug

Placebo

Drug

Primary outcomes

  1. Delta SOFA Score

    Time frame: 48 hours

    Sequential Organ Failure Assessment Score (0-24 range). Delta SOFA is calculated as (SOFA Score at 48 hours post enrollment minus SOFA Score at enrollment). A negative value indicates improvement in the score.

Sponsors and collaborators

Lead sponsor

University of Mississippi Medical Center

Other

Collaborators

  • National Institute of General Medical Sciences (NIGMS)

Registry information

Official study title

Phase 2 Study of Levo-Carnitine for Vasopressor Dependent Septic Shock

Acronym: RACE

Important dates

Study start
2013
Primary completion
2018
Study completion
2019
First posted
Aug 15, 2012
Registry last updated
Jun 4, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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